跳至主要内容
临床试验/NCT01560429
NCT01560429已完成4 期

Efficacy of Patient Controlled Epidural Anesthesia (PCEA) Versus Continuous Epidural Analgesia (CEA) for Post-thoracotomy Pain.

Queen's University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
52
试验地点
2
主要终点
Anesthetic Consumption (mg)

研究概览

简要总结

Postoperative thoracotomy pain is normally managed with an epidural catheter and continuous epidural analgesia (CEA). However, for some surgical procedures, patient controlled epidural anesthesia (PCEA) is more effective but little research has compared the two methods following thoracotomy. The current randomized, prospective clinical investigation did just this. Following institutional ethics approval 52 patients scheduled for thoracotomy were recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter was sited preoperatively. Postoperatively all patients were titrated on continuous epidural infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) until pain scores were stable at ≤3 on a numeric rating scale (NRS). Then they were allocated to their preoperatively determined randomization (either remained on continuous epidural infusion or they were switched to receive 2/3 of the stabilized background dose via continuous epidural infusion with the option to self-administer the remaining 1/3rd of the dose via PCEA. Participants remained on their allocated analgesic regimens for 48 hours postoperatively. The primary outcome was consumption of local anaesthetics/opioids. The secondary outcomes were worst pain and pain while coughing (0-10 NRS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-75 years of age
  • American Society of Anesthesiologist's (ASA) Physical Status I-III
  • Body Mass Index (BMI) < 40
  • Able to use a PCEA device

排除标准

  • Intolerance/hypersensitivity to agents used in the study
  • Contraindication to epidural placement
  • Current alcohol/substance abuse
  • Chronic pain condition requiring chronic analgesic
  • BMI ≥ 40 or body weight less than 50kg.

结局指标

主要结局

Anesthetic Consumption (mg)

时间窗: 4,8,12, 24 and 48 hours postoperatively

amount of anesthetic consumed was calculated for each group over time.

Local Anesthetic Consumption

时间窗: 48 hours postoperatively

Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA.

次要结局

  • Worst Pain While Coughing(48 hours postoperatively)
  • Worst Pain Scores(48 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Vidur Shyam

Principal Investigator

Queen's University

研究点 (2)

Loading locations...

相似试验

Efficacy of Patient Controlled Epidural Anesthesia... | 临床试验